In short
Clinical trials are studying Allogeneic T-Cell Precursors, Mobilized Peripheral Blood-Derived, Ex Vivo Cultured in people having haematopoietic stem cell transplantation for blood cancers. These trials aim to check safety and early efficacy, including whether immune cells recover after transplant. The main study is an early phase trial in adults receiving transplantation support.
Key points
- Clinical trials of Allogeneic T-Cell Precursors, Mobilized Peripheral Blood-Derived, Ex Vivo Cultured are being done in the setting of haematopoietic stem cell transplantation for blood cancers. The main study is an early Phase 1/2 trial with 59 participants. Researchers are looking first at safety, including unexpected unacceptable toxicities after infusion. They are also looking at early efficacy, especially whether T-cell recovery happens after transplant. The trial is authorised and focuses on people receiving transplant treatment.
Trial overview
The available trial is an early phase study of Allogeneic T-Cell Precursors, Mobilized Peripheral Blood-Derived, Ex Vivo Cultured, also called SMART101 in the trial record. It is being studied in the setting of haematopoietic stem cell transplantation for blood cancers.
Who is being studied
The trial focuses on people receiving treatment in haematopoietic stem cell transplantation for blood cancers. The source data do not give a full list of eligibility rules, but the study is clearly tied to the transplant setting.
Trial phase and design
This is a Phase 1/2 interventional study, which means the researchers are testing an active treatment and looking first at safety, dose selection, and early signs of benefit. The brief summary says Segment 1 is used to determine the recommended dose, and Segment 2 then looks at safety and activity.
What is being measured
The main safety endpoint is the occurrence of unexpected unacceptable toxicities within 28 days after SMART101 infusion. Toxicity means harmful effects or serious problems after treatment.
The main efficacy endpoint in Segment 2 is T-cell reconstitution rate, defined as a naïve CD4+ T cell count of at least 50/μL within 100 days after transplant, confirmed again on a later test within 2 months. In simple terms, the study checks whether a specific immune cell type returns after transplant.
Study status and size
The study status is listed as Authorised. The planned enrollment is 59 participants, which means the study aims to include 59 people in total.